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Study of Antibody for Methamphetamine Outpatient Therapy (STAMPOUT)

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ClinicalTrials.gov Identifier: NCT03336866
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
InterveXion Therapeutics, LLC

Brief Summary:
This study evaluates the ability of IXT-m200 to change methamphetamine concentrations in blood and alter the way methamphetamine feels. Participants will receive either placebo, a low or high dose of IXT-m200, in addition to methamphetamine challenge doses.

Condition or disease Intervention/treatment Phase
Methamphetamine-dependence Methamphetamine Abuse Drug: Placebo Drug: IXT-m200 Phase 1 Phase 2

Detailed Description:
IXT-m200 is a monoclonal antibody that binds to methamphetamine in the blood. The main purpose of this study is to look at the effects of IXT-m200 on the pharmacokinetics of methamphetamine and on methamphetamine liking effects. Additionally, the study will determine IXT-m200 pharmacokinetics, safety and tolerability in subjects with methamphetamine use disorder. Qualified subjects will receive a single dose of IXT-m200 followed by up to 4 methamphetamine challenge doses.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: STAMPOUT: Study of Antibody for Methamphetamine Outpatient Therapy
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Placebo Comparator: Placebo
Normal saline
Drug: Placebo
Normal saline

Experimental: IXT-m200
Single 6 or 20 mg/kg intravenous dose of IXT-m200
Drug: IXT-m200
IXT-m200 is an anti-methamphetamine monoclonal antibody
Other Name: ch-mAb7F9




Primary Outcome Measures :
  1. Change in serum methamphetamine (METH) area under the curve or Cmax resulting from METH challenge doses following single IV doses of IXT-m200 [ Time Frame: 29 days ]
    Measured by serum concentrations of METH over time


Secondary Outcome Measures :
  1. Change in subjective effects of METH challenge doses [ Time Frame: 26 days ]
    Measured by drug effects questionnaire (ie, reduction of 'High' or 'Liking')

  2. Safety and tolerability of IXT-m200 followed by METH challenges [ Time Frame: 126 days ]
    Measured by physical examinations and vital sign, adverse event, ECG, and clinical laboratory testing, and immune response by measurement of anti-IXT-m200 antibody levels

  3. Pharmacokinetics of IXT-m200 following single administration [ Time Frame: 126 days ]
    Measured by serum concentrations of IXT-m200 over time



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject voluntarily agrees to participate in this study and signs an informed consent form.
  • Subject must be able to verbalize understanding of the consent forms, provide written informed consent, and verbalize willingness to complete study procedures.
  • Males or females between 21 to 50 years of age, inclusive. Female subjects should be of non-childbearing potential or, they should be nonpregnant, nonlactating, and agree to use medically acceptable forms of birth control from screening to end-of-study follow-up, or have a partner who has had a vasectomy. Male subjects need to have had a vasectomy or agree to use a condom and spermicide in addition to their female partners using a form of birth control. They should agree not to donate sperm for 90 days post IXT-m200 dose.
  • Body mass index (BMI) between 18.0 and 35.0 kg/m2. Body weight ≥ 50 kg and ≤ 100 kg.
  • Subjects have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase) < 3 times the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 times the upper limit of normal.
  • Subjects meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for METH use disorder and are not seeking treatment at the time of the study.
  • Subjects will be experienced METH users with a history of non-therapeutic METH use for 2 or more years. Subjects must have experience with smoking or IV injection of METH.
  • Current METH use (past 30 days) less than daily, self-reported and documented by calendar-based timeline follow-back.
  • Primary current (past 30 days) route of METH self-administration other than IV (ie, smoking, snorting, or oral).
  • Subjects agree not to take METH from any source outside of the study during their participation in the study. Subjects agree not to take substances that are structurally similar to METH.
  • Subjects must provide a negative urine sample prior to admission to the unit on Day -1 for the study.

Exclusion Criteria:

  • Subjects who have been treated with a monoclonal antibody (mAb) in the past year.
  • Known or suspected allergy sensitivity to IXT-m200 based on known allergies to other mAbs.
  • History of severe allergy (rash, hives, breathing difficulty, etc) to any medications.
  • History of allergic or environmental bronchial asthma.
  • Clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, GI, cardiovascular, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous, or hematologic systems, or recent clinically significant surgery.
  • Current diagnosis or history of major psychiatric illness in the past two years or other current psychiatric condition requiring medication, other than methamphetamine dependence.
  • Considered by the PI to be at imminent risk of suicide or injury to self, others, or property, or the subject has attempted suicide with the past year. Past year history of, or current evidence for, suicidal ideation or those who were actively suicidal based on the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • Current dependence on alcohol or heavy use defined as >28 alcoholic drinks per week if male and >21 drinks per week if female in last 30 days.
  • Current dependence on other drugs except amphetamines, or marijuana and nicotine used in moderate amounts.
  • History of seizure, epilepsy, severe head injury with residual neurologic effects, multiple sclerosis, or stroke.
  • Abnormal pre-admission vital signs, physical examination, clinical laboratory, ECG, or any safety variable which is considered clinically significant for this population.
  • History of cardiovascular disease.
  • Treatment with any prescription medications or over the counter nutritional supplements within 14 days prior to the first dose of study medication.
  • Ingestion of any approved prescription anti-obesity drug or taken any over-the-counter medication for weight loss within a period of 90 days prior to the first dose of study medication.
  • Ingestion or use of any investigational medication or device within 30 days prior to the first dose of study medication.
  • Acute illness within 5 days prior to the first dose of study medication, eg, flu syndrome, GI virus, or clinically significant indigestion (eg, reflux).
  • Positive result for hepatitis B surface antigen (HBsAG), hepatitis C (HepC) antibody, hepatitis A immunoglobulin M (IgM), or HIV Viral Serology, or nucleic acid testing (NAT) tests at screening.
  • Positive breath alcohol test or positive urine drug test for illicit substances on Day -1.
  • Subjects with history of donated blood, plasma, or platelets in last 30 days, and who do not agree to refrain from blood, plasma, platelets, egg or sperm donation during the study period.
  • Predominant or only route of METH self-administration is IV.
  • Any subject judged by the PI or Sponsor (or designee) to be inappropriate for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336866


Locations
United States, Utah
PRA Health Sciences Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Denise Nordstrom    801-269-8200    NordstromDenise@prahs.com   
Principal Investigator: Lynn Webster, MD         
Sponsors and Collaborators
InterveXion Therapeutics, LLC
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Lynn Webster, MD PRA Health Sciences

Responsible Party: InterveXion Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT03336866     History of Changes
Other Study ID Numbers: M200C-1801
U01DA045366 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Methamphetamine
Immunologic Factors
Physiological Effects of Drugs
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors